Recipharm invests €1.2m in Italian small-scale API capabilities
The site in Paderno Dugnano, Italy was added to Recipharm’s manufacturing network when the firm acquired Corvette Pharmaceutical Services in 2014.
And today the contract development and manufacturing organisation (CDMO) has announced it has invested upwards of €1.2m ($1.3m) at the site to enhance its small scale GMP active pharmaceutical ingredient (API) capabilities on the back of growing demand for custom synthesis and early phase API manufacturing.
“Due to the patent cliff which is coming over the next few years, even small companies are shifting from the generics business to a sort of business which in the past was only performed by innovators,” Matteo Zacché, Recipharm’s R&D manager at Paderno Dugnano told in-Pharmatechnologist.com.
“Also, many health organisations are increasingly sponsoring research on rare diseases which have been mainly ignored by big pharma companies over the years. Because of this, many companies are searching for new molecules to be introduced as APIs, or even testing old molecules for different applications in early clinical phases to explore new business opportunities.”
He added the new R&D area and analytical development lab – which houses a team of eight - is already operational, while a new GMP-kilo lab is awaiting authorisation, expected by the end of the year.
Paderno Dugnano
The new plant will be the fourth manufacturing facility at the Paderno Dugnano site.
“One plant - batch sizes of around 300 – 400 kgs - is mainly manufacturing Erdosteine, a mucolytic which is the main API of the company,” Zacché told us. “The second one is a multi-purpose plant which manufactures various APIs, including anaesthetics, NSAIDs, anti-diabetes drugs, CNS drugs, cardiovascular and blood-pressure drugs.
“The third one is a small plant which is manufacturing niche APIs including cardiovascular drugs, Beta2-agonists and sedatives; this small plant serves a very niche market with an extremely high demand for quality and excellence in GMP manufacturing.”